Job Title : Scientist
Location : Devens, MA
Duration : 12 months
Pay range : $70 to $75.21 / hr on W2
Onsite / hybrid : 50% onsite (Tue, Wed, Thurs). First month will need to be onsite every day.
Work hours : 40 hours, Core hours are 9 : 00 - 4 : 00
Top 3 to 5 Skills or Must haves :
- Demonstrated Technical Writing Ability.
- Worked in Cross matrix Teams.
- Project Management - fast paced environment and can manage multiple projects at once.
- Independent Contributor - personable and can work with multiple stakeholders.
- Change Controls - GMP environments preferred.
- Investigation Experience.
- Bio Pharma experience preferred.
Job Description :
The Scientist in Manufacturing Sciences & Technology will support the Materials and Cryogenics Science group in the life cycle management of raw materials, consumables and single-use systems utilized for biopharmaceuticals commercial manufacturing operations. The successful candidate will collaborate closely with Manufacturing, Manufacturing Technology, Quality Assurance, Quality Control, Supply Chain, and Global Procurement groups on cross-functional teams.The subject matter expert for this position will be primarily required to :
Qualify alternative raw material suppliers :
Work with procurement to identify new suppliers.Recommend and / or lead necessary testing to qualify material for use in GMP manufacturing.Author technical equivalency assessments, specification comparisons and material characterization reports.Support risk assessments.Author change controls.Additional Tasks would include :
Support material and consumable manufacturing investigations.Evaluate and manage material associated supplier changes notifications to maintain GMP compliance.Support material specification development.Requirements :
Minimum BS / MS with 2+ years of industry experience post-graduation or PhD in Material Science Engineering, Chemistry or equivalent scientific background.Awareness of cGMP compliance and regulatory agency requirements.Demonstrated problem solving ability (familiarity with root cause analysis techniques and CAPAs a plus).Strong organizational, oral communication and technical writing skills.Effective team player and strong individual contributor.Familiarity with analytical techniques (FTIR, SEM-EDS, etc.).Knowledge of data trending and tracking, including use of statistical analysis software a plusTravel requirements : No
Physical requirements : No
Additional Job Requirements :
Lab w / o blood & animal